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Myocardial Damage In Patients With Cerebral Infarction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00306579
First Posted: March 24, 2006
Last Update Posted: August 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Fonden for Lægevidenskabelig Forskning for Fyns Amt.
Novo Nordisk A/S
AJ Andersen og Hustrus Fond
Overlægerådet Legatudvalg
Raimond and Dagmar Ringgård-Bohn's Foundation
Bankdirektør Hans Stener og hustru Agnes Steners legat
Odense University Hospital
Information provided by:
Danish Heart Foundation
  Purpose

Introduction

For several years "ischemic" electrocardiographic (ECG) changes in the acute phase of ischemic stroke have been reported. Whether these ECG changes reflect true myocardial ischemia remains controversial. So far no study has assessed different markers of myocardial ischemia or necrosis in consecutive patients admitted to hospital with an acute ischemic stroke.

Purpose

The main purpose of this study is to determine the potential burden of reversible and irreversible myocardial ischemia in patients with an acute ischemic stroke.

Patients and methods

Serial blood samples for measuring troponin T, CK-MB and NT-proBNP are collected in 250 patients with evidence of an acute ischemic stroke admitted to the Department of Neurology at Odense University Hospital. In addition resting 12-lead ECG recordings will be obtained on a daily basis, and a 24-hour ST-segment ambulatory monitoring will be performed once within the first week of hospitalisation. Finally, myocardial perfusion patterns during rest will be evaluated by means of a myocardial perfusion scintigraphy in patients with an elevated troponin T level.

Six months later control measurements of troponin T, CK-MB and NT-proBNP and a 12-lead ECG will be obtained.

Expectations

The study will contribute with original observations in patients with acute ischemic stroke considering the following issues:

  1. The prevalence and characteristics of ECG changes suggestive of myocardial ischemia.
  2. The prevalence of transient ST-segment changes on ambulatory monitoring.
  3. The prevalence and degree of myocardial necrosis as judged from biochemical markers.
  4. The prevalence of reversible and irreversible perfusion defects on myocardial scintigraphy.
  5. The prevalence, size and patterns of NT-proBNP.
  6. Whether there is a change in ECG and biochemical markers over a 6-month follow-up period.

The results may have clinical implications regarding early and late treatment as well as clinical follow-up of patients recovering from an episode of acute ischemic stroke.


Condition
Ischemic Stroke

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Myocardial Damage In Patients With Cerebral Infarction. Prevalence and Characteristics as Measured by Troponins, Electrocardiographic Changes and Myocardial Perfusion Imaging.

Further study details as provided by Danish Heart Foundation:

Estimated Enrollment: 250
Study Start Date: August 2003
Estimated Study Completion Date: May 2005
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Acute ischemic stroke.
  2. Age ≥ 18 years old.
  3. Written, informed consent.

Exclusion Criteria:

  1. Onset of stroke symptoms 8 to 21 days before admission.
  2. Transient ischemic attack.
  3. Intracerebral or subarachnoid haemorrhage.
  4. Previous myocardial infarction.
  5. Any pathological Q waves on the baseline ECG.
  6. Current atrial fibrillation.
  7. Unstable angina pectoris ≤ 3 weeks before admission.
  8. Systolic blood pressure ≤ 90 mmHg and symptoms.
  9. Resuscitation after cardiac arrest.
  10. Unwillingness to participate.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00306579


Sponsors and Collaborators
Danish Heart Foundation
Fonden for Lægevidenskabelig Forskning for Fyns Amt.
Novo Nordisk A/S
AJ Andersen og Hustrus Fond
Overlægerådet Legatudvalg
Raimond and Dagmar Ringgård-Bohn's Foundation
Bankdirektør Hans Stener og hustru Agnes Steners legat
Odense University Hospital
Investigators
Principal Investigator: Jesper K. Jensen, MD Department of Cardiology, Odense University Hospital
Study Director: Hans Mickley, DMSci Department of Cardiology, Odense University Hospital
Study Chair: Søren Bak, MD, PhD Department of Neurology, Odense University Hospital
Study Chair: Poul Flemming H. Carlsen, DMSci Department of Nuclear Medicine, Odense University Hospital
Study Chair: Søren R. Kristensen, DMSci Department of Clinical Chemistry, Aalborg Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00306579     History of Changes
Other Study ID Numbers: 054B26A43722225
First Submitted: March 23, 2006
First Posted: March 24, 2006
Last Update Posted: August 8, 2017
Last Verified: August 2017

Keywords provided by Danish Heart Foundation:
Ischemic Stroke
Myocardial ischemia
Myocardial necrosis

Additional relevant MeSH terms:
Infarction
Cerebral Infarction
Ischemia
Pathologic Processes
Necrosis
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases